Cleared Special

K132758 - DIGITAL ELECTROCARDIOGRAPH

K132758 is an FDA 510(k) clearance for DIGITAL ELECTROCARDIOGRAPH, manufactured by Shenzhen Biocare Bio-Medical Equipment Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Special 510(k) pathway after a 148-day FDA review.

K132758 · Shenzhen Biocare Bio-Medical Equipment Co., Ltd. · Cardiovascular device
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Jan 2014
Decision
148d
Days
Class 2
Risk

K132758 is an FDA 510(k) clearance for the DIGITAL ELECTROCARDIOGRAPH. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Shenzhen Biocare Bio-Medical Equipment Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on January 30, 2014 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Shenzhen Biocare Bio-Medical Equipment Co., Ltd. devices

FDA 510(k) Submission Details - K132758

510(k) Number K132758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2013
Decision Date January 30, 2014
Days to Decision 148 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 125d · This submission: 148d
Pathway characteristics
Modification to existing cleared device.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DPS Electrocardiograph

All 270
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